NCT05197426进行中（未招募）2 期
A Phase 2, Randomized, Double-Blind, Placebo-controlled Study to Compare Efficacy and Safety of Oral Azacitidine Plus Best Supportive Care Versus Best Supportive Care as Maintenance Therapy in Japanese Subjects With Acute Myeloid Leukemia in Complete Remission
Bristol-Myers Squibb57 个研究点 分布在 2 个国家目标入组 19 人开始时间: 2022年1月17日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 19
- 试验地点
- 57
- 主要终点
- Recurrence Free Survival (RFS)
研究概览
简要总结
The purpose of this study is to assess the efficacy and safety of oral azacitidine plus best supportive care versus best supportive care as maintenance therapy in a cohort of Japanese participants ≥ 55 years of age with Acute Myeloid Leukemia (AML) and in complete remission/complete remission with incomplete blood count recovery after conventional induction chemotherapy with or without consolidation chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 55 years of age inclusive at the time of signing the informed consent
- •Newly diagnosed, histologically confirmed de novo Acute Myeloid Leukemia (AML) or AML secondary to prior myelodysplastic syndrome (MDS) or chronic myelomonocytic leukemia (CMML)
- •Should have undergone induction therapy with intensive chemotherapy with or without consolidation therapy as recommended in appropriate guideline(s) or equivalent regimen according to institutional standard: having achieved first complete remission (CR)/complete remission with incomplete blood count recovery (CRi) status within 4 months prior to starting study therapy
排除标准
- •Suspected or proven acute promyelocytic leukemia; or AML with previous hematologic disorder such as chronic myeloid leukemia or myeloproliferative neoplasms, excluding MDS and CMML
- •Prior bone marrow or stem cell transplantation
- •Received therapy with hypomethylating agents for MDS and went on to develop AML within four months of discontinuing the therapy with hypomethylating agents
- •Have achieved CR/CRi following therapy with hypomethylating agents
- •Other protocol-defined inclusion/exclusion criteria apply
研究组 & 干预措施
Oral Azacitidine
Experimental
干预措施: Oral Azacitidine (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Other)
结局指标
主要结局
Recurrence Free Survival (RFS)
时间窗: Approximately 17.7 months
The time from randomization to the date of documented relapse after CR or CRi per central review, or death from any cause, whichever occurs first. Participants who are still alive without documented relapse after CR or CRi, or who were lost to follow-up without documented relapse, will be censored at the date of their last response assessment.
次要结局
- Overall Survival (OS)(Approximately 17.7 months)
- Time to Relapse From CR or CRi(Approximately 17.7 months)
- Time to Discontinuation(Approximately 17.7 months)
- Number of Participants With Treatment Emergent Adverse Events (TEAEs)(Approximately 17.7 months)
- Number of Participants With Clinically Significant Changes in Physical Examination(Approximately 17.7 months)
- Number of Participants With Clinically Significant Changes in Vital Signs(Approximately 17.7 months)
- Number of Participants With Clinically Significant Changes in Clinical Laboratory Examinations(Approximately 17.7 months)
- Number of Participants Who Received Concomitant Medication(Approximately 17.7 months)
- Mean Change From Baseline in Facit-Fatigue Scale(From C1D1 to C12D1 (approximately 336 days))
- Mean Change From Baseline in EQ-5D-5L(From C1D1 to C12D1 (approximately 336 days))
- Pharmacokinetic Evaluation: CMax(on C1D1 (after first dose on day 1))
- Pharmacokinetic Evaluation: Tmax(on C1D1 (after first dose on day 1))
- Pharmacokinetic Evaluation: AUC(0-T)(on C1D1 (after first dose on day 1))
- Pharmacokinetic Evaluation: AUC(INF)(on C1D1 (after first dose on day 1))
- Pharmacokinetic Evaluation: T-Half(on C1D1 (after first dose on day 1))
- Pharmacokinetic Evaluation: CLT/F(INF)(on C1D1 (after first dose on day 1))
- Pharmacokinetic Evaluation: Vz/F(on C1D1 (after first dose on day 1))
研究者
研究点 (57)
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